AzTrials
AzTrials

Locally Advanced Rectal Cancer (LARC)Phase 3TORCH-STARNCT07551479

SCRT Based iTNT vs. LCRT Based TNT for MSS Locally Advanced Rectal Cancer

A Phase 3 study testing short-course radiaotherapy, long-course chemoradiaothearpy and Capecitabine in people with Locally Advanced Rectal Cancer (LARC) and MSS (Microsatellite Stable), run by Fudan University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

In this prospective, multicentre, randomized phase III trial, 612 locally advanced rectal cancer (LARC, T3-4/N+M0) patients with at least one high-risk features (lower location (≤5cm), cT4, cN2, MRF+, EMVI+, TD+) will be included, and randomly assigned to TNT group and iTNT group (1:1). Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
short-course radiaotherapy, long-course chemoradiaothearpy and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
612 participants
Where
1 siteChina
Study dates
1 May 2026to 31 Dec 2035
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-75 years old, female and male;
  • Pathological confirmed adenocarcinoma;
  • The distance from anal verge ≤ 10 cm;
  • MSI/MMR status: MSS/pMMR;
  • Clinical stage T3-4 and/or N+, without distance metastases;
  • At least one of the following factors is present: distance from the anus ≤5 cm, cT4, cN2, positive cMRF, positive cEMVI, positive tumor deposit or positive lateral lymph node;
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  • KPS ≥ 70;
  • No radiotherapy, chemotherapy, immunotherapy, or any other anti-tumor therapy had been administered prior to enrollment;
  • Baseline blood and biochemical indicators meet the following criteria: neutrophils ≥ 1.5 × 10^9/L, Hb ≥ 90 g/L, PLT ≥ 100 × 10^9/L, ALT/ AST ≤ 2.5 ULN, Cr ≤ 1 ULN;
  • With good compliance and signed the consent form.

Who cannot join

  • Pregnancy or breast-feeding women;
  • Known history of other malignancies within 5 years;
  • Known history of severe neurological or mental illness (such as schizophrenia, dementia or epilepsy);
  • Current severe cardiac disease (cardiac dysfunction and arrhythmia), renal dysfunction and liver dysfunction;
  • Acute cardiac infarction or cerebral ischemic stroke occurred within 6 months before recruitment;
  • Uncontrolled infection which needs systemic therapy;
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  • Active autoimmune disease or immunodeficiencies, known history of organ transplantation or systematic use of immunosuppressive agents;
  • Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1 to 2 antibody positive), active syphilis infection, active pulmonary tuberculosis infection;
  • Allergic to any component of the therapy.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Zhen Zhang, MD, PhD contact

18801735029

zhen_zhang@fudan.edu.cn

China1 site

  • Fudan University Shanghai Cancer Center

    Shanghai

    Zhen Zhang, MD, PhD, 18801735029, zhen_zhang@fudan.edu.cn

    Yaqi Wang, MD, 18121299593, 10301010093@fudan.edu.cn

Other trials in China

About this study

Official title: SCRT Followed by CAPOX and PD-1 Inhibitor Versus LCCRT Followed by CAPOX in Total Neoadjuvant Treatment for High-risk LARC: A Prospective, Randomized, Multicenter, Phase III Study

In this prospective, multicentre, randomized phase III trial, 612 locally advanced rectal cancer (LARC, T3-4/N+M0) patients with at least one high-risk features (lower location (≤5cm), cT4, cN2, MRF+, EMVI+, TD+) will be included, and randomly assigned to TNT group and iTNT group (1:1). TNT group receives long-course chemoradiotherapy (50Gy/25Fx concurrent with oral capecitabine) followed by 6 cycles of CAPOX. iTNT group receives short-course radiotherapy (25Gy/5Fx) followed by 6 cycles of Serplulimab combined with CAPOX. After the efficacy evaluation, the patients who achieves clinical complete response (cCR) will be managed by a watch and wait (W\&W) protocol and non-cCR patients will be recommended surgery. The primary endpoint is 3-year event-free survival rate (3yEFS%). The secondary endpoints include the complete response (CR, pathological complete response [pCR] plus cCR) rate, 3-year organ preservation rate, 3-year disease-free survival rate (3yDFS%), 3-year local recurrence free survival rate (3yLRFS%), 3-year distant metastasis free survival rate (3yDMFS%), 3-year overall survival rate (3yOS%), grade 3-4 acute adverse effects (AE) rate, rate of surgical complications, anal functions and quality of life, etc.

Being tested
short-course radiaotherapy, long-course chemoradiaothearpy, Capecitabine, Oxaliplatin, PD-1 inhibitor
Keywords
Total Neoadjuvant Therapy, Immunotherapy, Survival Rate, Organ preservation, Locally advanced rectal cancer
Medical subject headings
Spinocerebellar Degenerations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • short-course radiaotherapyRadiation

    short-course radiaotherapy (25Gy/5Fx)

  • long-course chemoradiaothearpyRadiation

    long-course chemoradiotherapy (50Gy/25Fx concurrent with oral capecitabine 825mg/m2 bid d1-5 qw)

  • CapecitabineDrug

    Capecitabine: 1000mg/m2 bid d1-14 q3w

  • OxaliplatinDrug

    Oxaliplatin 130mg/m2 d1 q3w

  • PD-1 inhibitorDrug

    Serplulimab 300mg d1 q3w

Study groups in NCT07551479
Study groupRoleWhat they receive
TNT groupOtherTNT group receives long-course chemoradiotherapy (concurrent with oral capecitabine) followed by 6 cycles of CAPOX.
Receives: Radiation: long-course chemoradiaothearpy; Drug: Capecitabine; Drug: Oxaliplatin
iTNT groupExperimentaliTNT group receives short-course radiotherapy (25Gy/5Fx) followed by 6 cycles of Serplulimab combined with CAPOX.
Receives: Radiation: short-course radiaotherapy; Drug: Capecitabine; Drug: Oxaliplatin; Drug: PD-1 inhibitor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 3 year event-free survival rate

    Rate of 3 year event free survival

    Measured: From date of randomization until the date of first documented early local failure, disease progression during neoadjuvant therapy, pelvic recurrence, distant metastasis, or death, whichever came first, assessed up to 36 months.

Secondary outcomes (10)

  1. Complete response (CR) rate

    Rate of complete response (CR), including the rate of pathologic complete response (pCR) after surgery and the rate of cCR with W\&W strategy.

    Measured: 1 month after the surgery or the decision of W&W

  2. 3 year organ preservation rate

    3 year organ preservation rate

    Measured: From date of randomization until the resection of rectum or anus, assessed up to 36 months.

  3. 3 year disease free survival rate

    Rate of 3 year disease free survival

    Measured: From date of randomization until the date of first documented recurrence and metastasis after the completion of treatment or death from any cause, whichever came first, assessed up to 36 months.

  4. 3 year local recurrence free survival rate

    Rate of 3 year local recurrence free survival

    Measured: From date of randomization until the date of first documented pelvic failure, assessed up to 36 months.

  5. 3 year distant metastasis free survival rate

    Rate of 3 year distant metastasis free survival

    Measured: From date of randomization until the date of first documented distant metastasis, assessed up to 36 months.

  6. 3 year overall survival rate

    Rate of 3 year overall survival

    Measured: From date of randomization until the date of death from any cause, assessed up to 36 months.

  7. Grade 3-4 adverse effects rate

    Rate of chemotherapy, radiotherapy and immunotherapy related adverse events

    Measured: From date of randomization until 3 months after the completion neoadjuvant therapy

  8. Rate of surgical complications

    Rate of surgical complications

    Measured: The surgical complications were assessed within 1 year after the surgery.

  9. Low Anterior Resection Syndrome Score

    Evaluating the anal function using Low Anterior Resection Syndrome (LARS) score（range 0-42, with higher scores representing worse anal function）

    Measured: From date of randomization until five years after the completion of treament.

  10. Wexner Continence Grading Scale

    Evaluating the anal function using Wexner Continence Grading Scale (range 1-20, with higher scores representing worse anal function)

    Measured: From date of randomization until five years after the completion of treament.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2026
  2. Study start1 May 2026 (estimated)
  3. Primary completion31 Dec 2032 (estimated)
  4. Study completion31 Dec 2035 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
612 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07551479
Sponsor's protocol ID
FDRT-2025-665-4814
Acronym
TORCH-STAR
Status last verified
Apr 2026
First submitted
30 Mar 2026
Last updated
24 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing short-course radiaotherapy, long-course chemoradiaothearpy and Capecitabine in people with Locally Advanced Rectal Cancer (LARC) and MSS (Microsatellite Stable), run by Fudan University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zhen Zhang, MD, PhD (18801735029, zhen_zhang@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

3 year event-free survival rate (time frame: From date of randomization until the date of first documented early local failure, disease progression during neoadjuvant therapy, pelvic recurrence, distant metastasis, or death, whichever came first, assessed up to 36 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07551479.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.

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